MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VAGINAL MESH; STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Tract Infection (2120); Dyspareunia (4505); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Date 07/17/2017

Event Type  Injury  

Event Description

A urologist implanted a vaginal mesh from urinary incontinence.The mesh came for boston scientific.In 2015, i was contacted by a law firm called the (b)(6) law firm that had a class action suit against boston scientific mr.(b)(6) had me esign their form to represent me in this class action suit.I provided all the medical records they asked for and faxed to this firm right away.In 2017 i started to get a lot of uti and painful intercourse.I went to a specialist who did tests on me for urinary incontinence and told the dr.About the painful uti.My dr.(b)(6) diagnose my with a urethra fistula the mesh caused infection; fistula formation; inflammation; scar tissue formation; organ perforation; which caused pain during sexual intercourse; vaginal bleeding; chronic pelvic nerve damage and pain; which i receive nerve blocks and pain management.After surgery until current i had worsening urinary incontinence.I now pee all over the inside of my legs since the removal of this mesh.During surgery dr.(b)(6) took skin from my leg to make a sling for my bladder.I have suffer emotional pain and mental anguish during my recovery due to the pain and only having enough pain meds for three days until i could not stand it any more so i went to the er dept.Who give me morphine and percocet right away for my pain then the nurse remove the sutures from my leg.The problem i'm having now is this attorney who promise me compensation from boston scientific.For the removal of this mesh has made so many mistakes and no communication with me because of all the mistakes mr.(b)(6) has made in my case.I have called and called leaving message after message throughout the years and still no response from him.Mr.(b)(6) forgot to submit my claim during settlement.He finally submitted my claim during the hold back monies without all of my medical records.The special master made a decision to put me in tier 1 which is the lowest amount of money (b)(6), which i declined.I appeal his decision base on all that i had been through and supplied the medical records of my surgery and other records that mr.(b)(6) never submitted when he submitted my claim.The special master refused to accept any records dated after 2016; therefore the special master denied my appeal and stated he will only offer the (b)(6) which i declined again.On the packet the special master mailed to me stated if you don't understand you can call the 800 number on the back of his letter or get counsel from my attorney.I already knew, that my lawyer would never return my calls, so i called the 800 number.I got a call back stating they don't have any files on me.I am absolutely beside myself because mr.(b)(6) now wants a release from representing me.Which leaves me trying to find another attorney to take my case.I have called and called other attorneys who won't take my case and wont tell me why.Sincerely, (b)(6).Fda safety report id # (b)(4).

• Brand Name: VAGINAL MESH
• Type of Device: STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12324719
• MDR Text Key: 267672256
• Report Number: MW5103239
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 77